DERMABOND PRINEO Skin Closure System

Cutaneous Tissue Adhesive With Mesh

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Dermabond Prineo Skin Closure System.

Pre-market Notification Details

Device IDK152490
510k NumberK152490
Device Name:DERMABOND PRINEO Skin Closure System
ClassificationCutaneous Tissue Adhesive With Mesh
Applicant ETHICON, INC. ROUTE 22 WEST, P.O. BOX 151 Somerville,  NJ  08876 -0151
ContactDonna Marshall
CorrespondentDonna Marshall
ETHICON, INC. ROUTE 22 WEST, P.O. BOX 151 Somerville,  NJ  08876 -0151
Product CodeOMD  
CFR Regulation Number878.4011 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-01
Decision Date2015-11-25
Summary:summary

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